The Difference between Verification & Validation (V&V) Blog Feature
Michael J Lowe II

By: Michael J Lowe II on March 28th, 2016

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The Difference between Verification & Validation (V&V)

Quality Assurance

Working in the product development world is new to me, especially the medical sector. Much of the jargon is complex and difficult to remember. For example, it took me quite a while to finally nail down the difference between verification and validation. They have similar definitions, but are very different. Here’s the simple breakdown:

Verification is making sure you have been making the product correctly to the requirements you defined, it has the right parts, and it is assembled the correct way. Think of it as an internal review of all the inputs, bits, and pieces used to make a finished item. Look at this image for illustration. It starts at user needs and flows down to a finished device.

VandV_Flow.png

Validation is ensuring that you made the correct product overall. Think of it as the big picture: did you come out with the finished product that your customer wanted? That is not as simple as it may sound. Companies pay people millions of dollars (I am not joking) to do V&V work on their projects. There are thousands and thousands of items to do V&V work on in every product a medical device company makes.

It’s simple when you think of it visually as in the graphic above. Hopefully, this write up helps you to remember verification is inside the product and validation is the product.

More Information on Verification & Validation

Download our whitepaper, Differences Between Verification and Validation, part of our Design Controls White Paper Series.

Download the Cognition Design Controls Series Part 5: Verification & Validation